1. Field of the Invention
This application relates to catheters, for example urinary catheters, such as indwelling and intermittent catheters, and relates more specifically to intermittent catheters comprising a hypoallergenic or non-allergenic, synthetic polyisoprene based formulation.
2. Description of the Related Art
Catheters suitable for draining the bladder include both intermittent and indwelling catheters. Indwelling catheters include Foley catheters. Foley catheterization is typically indicated for surgical and medical patients who require, at least temporarily, assisted bladder voiding. Common indications to catheterize a patient include acute or chronic urinary retention (which can damage the kidneys), medical procedures (i.e., surgeries) that may at least temporarily limit a patient's movement, the need for accurate monitoring of input and output (such as in an ICU), benign prostatic hyperplasia, incontinence, and the effects of various surgical interventions involving the bladder and prostate.
A standard Foley catheter design includes a balloon disposed at the distal end of the catheter to anchor the catheter in the bladder. The catheter includes at least one lumen to drain urine from the bladder and at least one lumen to inflate the balloon (e.g., with sterile water). The proximal end of the Foley catheter includes at least two ports in communication with the two lumens. A first port is connected to the drainage lumen and has an interface with fittings for drainage and sampling. A second port is connected to the inflation lumen with a valve to ensure the inflation fluid remains within the lumen and balloon once filled. The tip of a standard Foley catheter extends beyond the sides of the balloon into the bladder and includes one or more apertures or “eyes” to drain fluids and debris from the bladder. This standard design has not changed in many years, although catheters with various additions (e.g., mechanical anchors, etc.) and improvements have been proposed and investigated.
A typical intermittent catheter differs from an indwelling catheter primarily in that the intermittent catheter does not have a retention balloon or an associated inflation lumen. Rather, the intermittent catheter is typically a single-lumen device, with multiple drainage eyes at the proximal end and a funnel at the distal end. Intermittent catheterization is often performed in individuals with malfunctioning urinary systems (e.g., suffering from strictures and traumas), as well as disabled individuals (e.g., para- or quadriplegics) who may be unable to voluntarily urinate. Such individuals will often self-catheterize with an intermittent catheter several times daily.
Intermittent catheters are generally catheters or tubes having a rounded tip connected to a distal end that is inserted into the bladder of a user or user. A molded funnel connected to a proximal end remains outside the body of the user. These types of catheters are typically utilized on a temporary, as-needed basis to remove urine from the bladder of a user. The distal tip may include slots or openings in the shaft to facilitate drainage of urine therefrom once the tip is positioned inside the bladder.
Intermittent catheters are typically disposable, although intermittent catheters exist which are designed to be cleaned and reused. Intermittent catheters are typically manufactured from natural rubber latex, or, in some cases, polyvinyl chloride (PVC). Pre-wetted intermittent catheters are intermittent catheters having a lubricious coating on an outer surface thereof. Pre-wetted catheters are either packaged in a wetting fluid or packaged dry and soaked in a wetting fluid after they are removed from their packaging in order to provide a catheter with a slippery outer surface to facilitate insertion into the user.